Cleared Special

K130786 - SLEEK OTW PTA CATHETER

K130786 is an FDA 510(k) clearance for SLEEK OTW PTA CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 43-day FDA review.

K130786 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
43d
Days
Class 2
Risk

K130786 is an FDA 510(k) clearance for the SLEEK OTW PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Enniscorthy, Co. Wexford, IE). The FDA issued a Cleared decision on May 3, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130786

510(k) Number K130786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2013
Decision Date May 03, 2013
Days to Decision 43 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 388
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K130786.
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K130293 · Cook, Inc. · May 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · Bard Peripheral Vascular, Inc. · May 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · Ev3, Inc. · May 2013
PASSEO-35
K130161 · Biotronik, Inc. · Apr 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · Ev3, Inc. · Feb 2013
PACIFIC PLUS
K123358 · Medtronic Vascular · Jan 2013
K130786 · SLEEK OTW PTA CATHETER
Download PDF FDA Summary C.R. Bard, Inc.